Theraflu Daytime Severe Cold

Acetaminophen is used to relieve pain and reduce fever.

Phenylephrine is a decongestant that helps narrow blood vessels in the nasal passages. When blood vessels are wider, it can lead to nasal congestion (a stuffy nose).

Theraflu Daytime Severe Cold is a combination medicine that helps treat headache, fever, body aches, a stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Theraflu Daytime Severe Cold may also be used for other reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can harm your liver or cause death. Call your doctor immediately if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

You should not use Theraflu Daytime Severe Cold if you are allergic to acetaminophen (Tylenol) or phenylephrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• high blood pressure, heart disease, coronary artery disease;
• overactive thyroid;
• pheochromocytoma (an adrenal gland tumor); or
• if you take an anti-depressant.

It is not known whether Theraflu Daytime Severe Cold will harm an unborn baby. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use cough or cold medicine without a doctor's advice if you are breastfeeding.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be life-threatening. This can happen even if you have taken acetaminophen before without any issues. Stop taking Theraflu Daytime Severe Cold and call your doctor immediately if you have skin redness or a rash that spreads and leads to blistering and peeling. If you experience this type of reaction, you should never again take any medicine that contains acetaminophen.

The medicine may cause serious side effects. Stop using the medicine and call your doctor right away if you have:

• fast, slow, or uneven heart rate;
• confusion, hallucinations;
• tremor, seizure (convulsions);
• little or no urinating;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, shortness of breath, seizure).

Common side effects of Theraflu Daytime Severe Cold may include:

• dizziness, weakness;
• mild headache;
• mild nausea, diarrhea, upset stomach;
• runny nose;
• feeling nervous, restless, or anxious; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since Theraflu Daytime Severe Cold is taken when needed, you may not have a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can be deadly.

The first signs of an acetaminophen overdose include not wanting to eat, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

This medication may affect your thinking or reactions. Be cautious if you drive or do anything that needs your full attention.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can lead to too much acetaminophen, which can cause a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while using acetaminophen.

Other drugs may interact with acetaminophen and phenylephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all the medicines you are currently using and any medicine you begin or stop using.